Skip to main content
OpenTrials
Completed

NCT Number: NCT01115998

Effect of Power Wheelchairs on the Development and Function of Young Children With Severe Physical Disabilities

Self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. As a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. To compensate, power mobility has increasingly been advocated for young children with severe motor impairments. The study hypotheses were:

1. Children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility. 2. Parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

Completed

Looking for future studies?

Notify Me

Key information

Age range

14 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 78104, United States

About this study

More extensive description is not desired.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 14 to 30 months
  • Motor impairment that prevents functional independent mobility
  • Vision and hearing adequate to use a power mobility device safely.
  • Cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.

Treatment and study plan

Power wheelchair

Other

Children used power wheelchairs for one year. They continued to receive their usual early intervention services.

Other names: Invacare Power Tiger wheelchairs

No power wheelchairs

Other

Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.

Primary outcomes

  1. Pediatric Evaluation of Disability Inventory

    Time frame: Baseline and 12 months

    Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.

  2. Battelle Developmental Inventory (BDI)

    Time frame: Baseline and 12 months

    Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.

  3. Early Coping Inventory

    Time frame: Baseline and 12 months

    We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

Learning Early Travel Skills: Effects of Power Mobility on the Development of Young Children With Severe Motor Impairments

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
May 4, 2010
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.